Subjective Memory Impairment
Conditions
Brief summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.
Detailed description
Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;
Interventions
DIETARY_SUPPLEMENTSkate group
This group takes 500 mg/day Skate Skin extract for 12 weeks
DIETARY_SUPPLEMENTPlacebo group
This group takes 500 mg/day Placebo for 12 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Global Deterioration Scale (GDS) 2 or 3
Exclusion criteria
* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL) * Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL) * History of viral hepatitis or cancer * Uncontrolled hypertension * History of serious cardiac disease such as angina or myocardial infarction * History of gastrectomy * History of medication for psychiatric disease * Administration of oriental medicine including herbs within the past 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination total score | Change from Baseline Mini-Mental State Examination total score at 3 months | Change in Mini-Mental State Examination total score during 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Korean instrumental activity of daily living total score | Change from Baseline Korean instrumental activity of daily living total score at 3 months | Change in Korean instrumental activity of daily living total score during 3 months |
| Computerized NeuroCognitive Function test total score | Change from Baseline Computerized NeuroCognitive Function test total score at 3 months | Change in Computerized NeuroCognitive Function test total score during 3 months |
| brain derived neurotrophic factor | Change from Baseline brain derived neurotrophic factor level at 3 months | Change in brain derived neurotrophic factor level during 3 months |
Countries
South Korea
Outcome results
None listed